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VISTOGARD Drug Profile
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» See Plans and PricingWhen do Vistogard patents expire, and what generic alternatives are available?
Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
US ANDA Litigation and Generic Entry Outlook for Vistogard
Vistogard was eligible for patent challenges on September 4, 2019.
Indicators of Generic Entry
Summary for VISTOGARD
| International Patents: | 175 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 57 |
| Patent Applications: | 60 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | VISTOGARD at DailyMed |
Pharmacology for VISTOGARD
| Ingredient-type | Pyrimidines Analogs/Derivatives |
| Drug Class | Pyrimidine Analog |
Synonyms for VISTOGARD
| (2R,3R,4R,5R)-2-(ACETOXYMETHYL)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1(2H)-YL)TETRAHYDROFURAN-3,4-DIYL DIACETATE |
| 105T388 |
| 2 ,3 ,5 -Triacetyluridine |
| 2',3',5'-Tri-O-acetyluridine |
| 2',3',5'-Tri-O-acetyluridine, >=98% |
| 2',3',5'-Triacetyluridine |
| 293738-13-3 |
| 2WP61F175M |
| 4-Hydroxy-1-(2,3,5-tri-O-acetylpentofuranosyl)pyrimidin-2(1H)-one |
| 4105-38-8 |
| AK-73070 |
| AKOS015964563 |
| ANW-29551 |
| API0001026 |
| AUFUWRKPQLGTGF-FMKGYKFTSA-N |
| AX8007900 |
| CHEBI:90914 |
| CHEMBL2107381 |
| CS-D1799 |
| CTK3J5861 |
| D09985 |
| DB09144 |
| DTXSID70951914 |
| EINECS 223-881-5 |
| FT-0081134 |
| HY-14905 |
| J-700012 |
| KSC495Q6D |
| MFCD00023795 |
| MLS006009982 |
| PN 401 |
| PN-401 |
| PN401 |
| PubChem14176 |
| Q22075857 |
| RG 2133 |
| RG-2133 |
| RG2133 |
| s6484 |
| SB18970 |
| SCHEMBL871011 |
| SMR004701034 |
| Tri-O-acetyluridine |
| triacetyl uridine |
| Triacetyluridine |
| UNII-2WP61F175M |
| URI007 |
| Uridine 2',3',5'-triacetate |
| Uridine triacetate |
| Uridine triacetate (USAN/INN) |
| Uridine triacetate [USAN:INN] |
| Uridine, 2',3',5'-triacetate |
| Vistogard (TN) |
| Vistonuridine |
| Xuriden |
| Xuriden (TN) |
| ZINC3843198 |
US Patents and Regulatory Information for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VISTOGARD
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 3474073 | Start Trial |
| Finland | 970588 | Start Trial |
| Austria | 97574 | Start Trial |
| Germany | 69229108 | Start Trial |
| Japan | 2007332144 | Start Trial |
| China | 1089239 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VISTOGARD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1849470 | 2017/033 | Ireland | Start Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | 1790063-0 | Sweden | Start Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 17C1028 | France | Start Trial | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | CA 2017 00036 | Denmark | Start Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 2017C/028 | Belgium | Start Trial | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| 1849470 | LUC00036 | Luxembourg | Start Trial | PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
